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Hiring Associate GRAAS Operations
🏢 Amgen
📍 Hyderabad
🎓 Freshers / Early Career
📊 Regulatory Affairs
Amgen is hiring an Associate – GRAAS Operations. This role is ideal for candidates interested in Regulatory Affairs, GSIM, and clinical data management.
📋 Job Overview
- Role: Associate – GRAAS Operations
- Location: Hyderabad
- Department: Regulatory Affairs
- Type: Full-Time
- Domain: GSIM / Regulatory Data
📌 Key Responsibilities
- Monitor regulatory data and submission timelines
- Update regulatory document systems (RSDIMS)
- Manage clinical trial submissions
- Handle FDA Form 1572 & PANI submissions
- Maintain regulatory archives
- Support cross-functional teams
🎓 Education & Experience
Basic Requirements:
- Bachelor’s degree
- OR Associate’s degree + 4 years experience
- OR High School / GED + 6 years experience
Preferred:
- Experience in Regulatory Affairs operations
- Understanding of regulatory processes (FDA, EMA)
- Exposure to document systems (Veeva preferred)
💻 Required Skills
- Regulatory data management
- GMP awareness
- Attention to detail
- Communication skills
👉 Learn basics: Clinical Research Guide
💰 Salary & Benefits
- ₹4.5 – ₹8 LPA
- Global regulatory exposure
- Career growth in Regulatory Affairs
- Work with international teams
💡 Interview Tips
- Revise FDA & EMA basics
- Understand clinical trial process
- Learn document workflows
- Practice Quiz
📄 Resume Tips
- Add regulatory knowledge
- Highlight documentation experience
- Mention certifications
- Keep resume 1–2 pages
❓ FAQ
- Freshers eligible?
Yes (early career) - Location?
Hyderabad - Domain?
Regulatory Affairs - Growth?
Strong RA career path
🚀 Job Application Link
📌 Important Note Before You Apply:
Kindly read the entire job description carefully before applying. Ensure your profile aligns with Global Regulatory Affairs and Safety (GRAAS) operations, regulatory submissions management, compliance documentation, and life sciences data tracking before proceeding.
Kindly read the entire job description carefully before applying. Ensure your profile aligns with Global Regulatory Affairs and Safety (GRAAS) operations, regulatory submissions management, compliance documentation, and life sciences data tracking before proceeding.
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